Efficiency of Sonic Activation During Root Canal Treatment of Primary Molars on Postoperative Pain and Facial Expressions

NCT ID: NCT07138937

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-03-01

Brief Summary

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This study was conducted to evaluate the efficiency of sonic activation of 5%sodium hypochlorite during root canal treatment of primary molars on postoperative pain and facial expressions. In addition to comparing between the Five-face pain scale and AI Emotion Detector mobile application in postoperative pain assessment.

Detailed Description

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The current study addresses an important gap in research, as the impact of sonic activation of irrigation on postoperative pain in children and the validity of artificial intelligence mobile application in detecting facial expressions following root canal treatment as not been well explored.

Conditions

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Root Canal Treatment in Children Primary Molars Postoperative Pain Facial Expressions Facial Emotions Artificial Intelligence Mobile Application Sonic Activation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A comparative, randomized, prospective clinical trial to evaluate the efficacy of sonic activation versus no activation by comparing the pain scale and facial expressions following root canal treatment in primary molars.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Sonic activation of irrigation

Sonic activation of irrigation with Eddy system

Group Type ACTIVE_COMPARATOR

Root canal treatment in primary molars with irreversible pulpitis

Intervention Type PROCEDURE

Root canal treatment in primary molars with irreversible pulpitis followed by coronal restoration with stainless-steel crowns in a single visit.

EDDY system for sonic activation of irrigation

Intervention Type DEVICE

sonic activation of irrigation with EDDY system during root canal treatment in primary molars

No activation

Irrigation with side-vented needle without activation

Group Type PLACEBO_COMPARATOR

Root canal treatment in primary molars with irreversible pulpitis

Intervention Type PROCEDURE

Root canal treatment in primary molars with irreversible pulpitis followed by coronal restoration with stainless-steel crowns in a single visit.

side-vented needle

Intervention Type DEVICE

conventional irrigation with side-vented needle without activation during root canal treatment in primary molars

Interventions

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Root canal treatment in primary molars with irreversible pulpitis

Root canal treatment in primary molars with irreversible pulpitis followed by coronal restoration with stainless-steel crowns in a single visit.

Intervention Type PROCEDURE

EDDY system for sonic activation of irrigation

sonic activation of irrigation with EDDY system during root canal treatment in primary molars

Intervention Type DEVICE

side-vented needle

conventional irrigation with side-vented needle without activation during root canal treatment in primary molars

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Children's age range 5-8 years. Boys and girls will be included.
2. Children with positive or definitely positive behavior on the Frankl's behavior rating scale (rating 3 or 4 on the scale).
3. Children with at least one primary molar with irreversible pulpitis and symptomatic apical periodontitis confirmed using periapical radiographs, percussion, and cold test.
4. Children having teeth with two-thirds of each root remaining.
5. Children with a moderate to very severe (2-4) pain score according to five-face pain scale in only one tooth within the 24-h period before the procedure.
6. Children with no allergy to Ibuprofen.

Exclusion Criteria

1. Teeth with pathological root resorption.
2. Teeth with mobility greater than 1st-degree mobility.
3. Children who received analgesics and/or antibiotics in the last 12 h before root canal treatment
Minimum Eligible Age

5 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suez Canal University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ghada Abdelhamid El-Baz, Professor of Pedodontics

Role: STUDY_CHAIR

Faculty of dentisrty, Suez Canal University

Locations

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Faculty of Dentistry Suez Canal University

Ismailia, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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728/2024

Identifier Type: -

Identifier Source: org_study_id

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